Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+/HER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment

Sponsor
West German Study Group
Study ID
NCT07281833
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Capivasertib — DRUG
    2x400 mg, peroral, for 4 days, followed by 3 days off treatment

Study Details

This is a multicentre phase-III-trial to evaluate the use of capivasertib in patients with HR+/HER2- advanced breast cancer and progression on prior endocrine-based treatment. The goal of this study is 1. To evaluate benefit of capivasertib regarding time to next treatment (TTNT1) - i.e., time "on treatment" with capivasertib. 2. To evaluate the benefits of patient reported outcome(PRO)-adherence regarding the deterioration of quality of life (DQoL)-free interval. There is no active comparison group but a historical control group consisting of data of patients treated within the CAPItello-291-study.. Participants will take capivasertib accompanied by standard of care endocrine treatment and are asked to document ther quality of life on standardised questionnaires. Optionally, patients can use eHealth support via their own smart phones.

Key Dates

First listed
Dec 15, 2025
Start date
Nov 27, 2025
Status verified
Feb 2026
Primary completion
Mar 31, 2030
Completion
Mar 31, 2030

Study Design

Enrollment
250 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Capivasertib
    2x400 mg, peroral, for 4 days, followed by 3 days off treatment

Primary Outcome Measure

Superiority* of TTNT1 in patients receiving capivasertib compared to an evidence-based "standard TTNT1 curve" for patients without capivasertib. [ Time Frame: Last-patient-in plus 12 months ]

Central Contacts

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